This combination introduces unique opportunities for improved usability and improved patient outcomes. It also poses new risks for patient safety. Just as with mobile phones and tablets, as the devices become more commonplace and the potential value of accessing those devices increases, the number and nature of malicious attacks is likely to increase substantially. Here is a brief overview of the opportunities to enhance the patient experience with these new technologies, and the kind of steps that can mitigate some of the more common attack vectors.

Yes -- your new glucose pump is vulnerable, as are other medical devices. Even if it is still just an idea known only to you, it is vulnerable to kidnapping and sodium pentothal. Of course, that does not mean we should stop thinking of new ideas for glucose pumps that can dramatically improve patient outcomes, and/or patient quality of life, or that reduce costs, or in other ways improve the overall practice of healthcare. While the example of kidnapping and “truth serum” may sound extreme, it highlights two key observations: every device has vulnerabilities, and many times the risk of these vulnerabilities being exploited is acceptable.

This article will explore some of the more common usability enhancements available for medical device manufacturers today, vulnerabilities, and exploits associated with those enhancements, and some suggestions for approaches that may mitigate the risk of exploitation. This article is not a prescription for a completely secure device. One important element of security measures is keeping them secret. When you develop a security strategy for your new device, be sure not to overlook the fact that limiting the number of people with detailed knowledge of your strategy limits the risk of successful attacks.

While it is not possible to outline a specific set of measures that will work for every product for any specific vulnerability, it is possible to outline a process that includes the key steps needed to create a formal security strategy for your new device.

Decide what to protect
The very first step is to decide what is important to protect. Your strategy will depend on whether you are protecting company IP, patient data, patient safety, or preventing unauthorized service usage. Start by recognizing that you cannot eliminate all exploitation risk for any vulnerability, and decide what level of time, effort, and cost are justified to address the identified vulnerabilities. Keep your security strategy secret.

The fewer people who know the details of the security measures you have put in place, the longer those measures are likely to be effective. For each of the vulnerabilities that you need to address, consider layered strategies -- use a password and a proprietary data format to protect patient data, use secure EEPROM and online verification to protect the integrity of your executable software image. Finally, create a plan to provide updates or patches in the event that an exploit does become widely available or widely known.

Determine how to protect it
The list of hardware features that enhance usability of consumer (and medical) devices is relatively ubiquitous: Ethernet, WiFi, Bluetooth (BT), USB, GPS, accelerometers, haptic, touch, and audio. Less prevalent technologies like FireWire (IEEE1394), ZigBee, and NFC are also beginning to enter the mainstream. Generally, they fall into a few different categories in terms of the enhancements they provide.

Using a unique data format is an often overlooked area of security. Simply packing bytes and using bit fields not only makes the data packet smaller, but does prevent all bit the technically savvy from monitoring the data.

I certainly see your point, Alan. Current trends are taking technology usage out of the hands of specialists and into those of less technical users who may inadvertently create a security breach that allows sensitive information to either be accessed or corrupted. Networking is definitely on the increase in medical applications for easier sharing of data - I can see how this increases the need for security...

Thanks all for your comments on the article. Apologies for the delay in responding. I lost track of when the article was going live. I think there are three main contributors to the cost of medical devices. One is definitely the higher development costs to meet regulatory and safety requirements. However the "typical" medical device takes much less overall cost to develop than the iPhone for example. Liability is another big piece, and I think the third important piece is the relatively low volumes. At Logic PD I have worked with a variety of very recognizable device manufacturers, and volumes for some of the devices that we've worked on with large-scale development efforts can be in the 100's per year. If you sell only about 1,000 in ten years every million you spend on development adds $1000 to the cost of each unit. Such low volumes also increases the cost of the components that go into the device (buying a million memory chips is a much lower unit cost than buying 100).

Nancy, first off apologies for the delay in responding. I lost track of when the article was going live. Absolutely most of what I described is generally applicable to consumer devices as well as medical devices. Device and information security is generally a fairly mature and active area of development, and I was trying to illustrate some of the areas where medical device designers and manufacturers should be paying more attention to security, in an environment that historically has had fewer security concerns (non-networked devices, used in controlled environments, by trained health care professionals).

Greg, first off apologies for the delay in responding. I lost track of when the article was going live. I agree completely. The focus of the article was intended to be FDA regulated devices, not so much data protection that would be governed by HIPAA. In fact I was motivated to write because of the reports in 2011 that an insulin pump had been successfully hacked, and was able to be programmed maliciously over a wireless connection.

Charles, first off apologies for the delay in responding. I lost track of when the article was going live. The level of level of security depends on the safetly classification of the device. In cases of lowest patient risk something like SELinux or SEAndroid (Security Ehanced) may be appropriate. In cases of higher risk most closed source OS options that offer packages specifically for medical device development will be closed-source, and provide an appropriate level of security as a starting point. In terms of networked devices one aspect of security outside scope of my post is IT policy. The range and nature of devices that connect to your network, and whether or not persistent storage is all encrypted, and whether it's possible to install new apps, etc all contribute to overall security.

From a patient safety standpoint, I'm not as concerned with the pirating of medical information as I am about a hacker who infiltrates the medical device with malicious intent. I think we should consider ways to mitigate hacker risk if a medical device is connected to a network and could be vulnerable to an attack on its operating system (where applicable).

The high cost of medical devices is due in part to a longer history of liability problems than of leaked data, a much more recent concern. Other factors like very high performance and the high cost of middlemen no doubt contribute yet more cost. But I think Cabe's point about leaked data is a good one--that's probably going to be a contributing factor to higher device costs in the near future.

Practically all electronic devices today contain metals that may
be coming from conflict-ravaged African countries. And political pressures will increasingly influence how these minerals are sourced and used in products.

Design for manufacturing (DFM) in mold production means that mold designers evaluate the manufacturability of their molds in the early stage of mold development by collecting all relevant information and applying it to their designs. They also have to consider many other factors, including flow balance, structural stress, and assembly tolerance, in order to ensure successful molding production.

Some adhesives provide strong structural bonds but take hours to fixture and attain handling strength. The technologies that offer the fastest cure do not bear loads or withstand stresses. A new class of adhesives aims to make both stick.

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